PROCEEDINGS [9:00 a.m.]

Agenda Item: Call to Order, Welcome and Introductions – Mr. Reynolds

MR. REYNOLDS: Good morning, this is a meeting of the Standards and Security
Subcommittee of the National Committee on Vital and Health Statistics. NCVHS is
a primary health advisory committee to the Secretary of Health and Human
Services on health related matters. The meeting today will be broadcast over
the internet and recorded. I am Harry Reynolds, Blue Cross and Blue Shield of
North Carolina, co-chair along with Jeff Blair.

We’ve got an agenda that I’ll go over after everybody introduces themselves
and as we do the introductions of everyone present, and then we’ll ask who’s on
the, and I believe we’ve got one of our committee members on the phone, I’ll
start around the table and I ask members of the committee to identify any
possible conflicts of interest that they may have based on today’s agenda. Also
I’ll let the introductions go and we have a new lead staff member, Denise
Buenning, that we’ll talk a little more about but I’ll let her introduce
herself just briefly for the record and then we’ll welcome her officially as
part of the agenda. I have no conflicts with what’s coming in today, Jeff.

MR. BLAIR: Jeff Blair, co-chair of the Subcommittee on Standards and
Security, director of health informatics at Lovelace Clinic Foundation and I’m
not aware of any conflicts of interest.

DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention,
staff to the subcommittee and liaison to the full committee.

DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of
the committee and the subcommittee, no conflicts.

MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and executive secretary to the committee.

MR. SUAREZ: I’m Walter Suarez, I’m with the Institute for HIPAA and HIT
Education and Research, and I’m one of the presenters this morning.

MR. MCLAUGHLIN: I’m Mark McLaughlin, current chairman of the WEDI Board of
Directors.

DR. FERRER: I’m sorry, this is Jorge Ferrer from the VA, staff to the
subcommittee.

MR. REYNOLDS: Any other members of the committee or staff on the telephone?

Okay, just to quickly go through the agenda, we’re going to first hear from
a group from WEDI on the NPI implementation issues and concerns that they’re
dealing with. Then our second group would be a continuing environment on our
work on the CHI initiatives. After our break we’ll talk a little bit about
where we’re going forward from here but there’s three major items that we want
to at least discuss is the letter on matching records to patients, we’re going
to get an update, Karen and Denise have been gracious enough to give us a short
discussion on e-prescribing and the DEA meeting that went on last week so we
will be able to do that, and then we’ve got to look at our, at least spend a
few minutes on our portfolio going forward, we have our next hearings scheduled
for October and then we had a possible one at least penciled in in the December
timeframe.

If Denise, how about telling us a little bit about what you do, we’re
excited to have you with us and we’d love to hear a little more about you
because you’re going to be a major, major player in this committee.

MS. BUENNING: No pressure here. I am Denise Buenning, I am with the Office
of E-Health Standards and Services at CMS, I joined the group back in April and
prior to that I have experience with the agency, I was with the Kansas City
Regional Office, like Judy, I also have a daughter at University of Kansas so
it’s a like a connection there. I worked in the Kansas City Regional Office for
eight years doing beneficiary outreach and transitioned to the central office
where I was the deputy in the beneficiary outreach area and made the transition
over to e-health standards and services. I do have background in HIPAA, a
number of years ago did a detail with what was the Office of HIPAA Standards at
that time and obviously working very hard to bring everybody up to speed on a
number of different areas, integrated data strategy and e-prescribing, which I
know everybody has a great interest in. And just working to push forward the
recommendations and the work that this subcommittee and all of our other
committees are working on. I’m looking forward to working with you all.

MR. REYNOLDS: Great, well we’re really happy to have you as part of our team
and we appreciate it, and isn’t it interesting how people now are proud that
they were involved in HIPAA during that time —

MS. BUENNING: For me it was a great experience.

MR. REYNOLDS: It was for all of us, I just say it’s been an interesting
transition to watch that.

So let’s start our first panel and we have Mark McLaughlin and Walter Suarez
that are going to talk about the NPI implementation.

MR. MCLAUGHLIN: Mr. Chairman and members of the subcommittee I am Mark
McLaughlin with the WEDI Board of Directors and I would like to thank you for
the opportunity to present testimony on the current status of National Provider
Identifier implementation.

WEDI has been very involved in the development of the progression of the
National Provider Identifier, NPI, the following is a summary of that work.
WEDI has established the National Provider Identifier Outreach Initiative,
NPIOI, the NPIOI officially launched in September of 2005 to serve as the focal
point to the industry for information related to the planning, transition and
implementation of the NPI. Walter is going to provide a little bit more detail
regarding the efforts of that group in just a moment.

The WEDI Strategic National Implementation Process, or SNIP as it’s called
in WEDI, NPI Subworkgroup has established and published 12 white papers on
various NPI topics.

Jim Whicker, as you may recall, the current chair-elect for the WEDI Board
of Directors, provided NPI testimony to NCVHS in April with the review and the
assistance of the NPI Subworkgroup and NPIOI Workgroup.

The NPI Subworkgroup has also conducted a couple of NPI introductory
audiocasts and it’s interesting to note that we had over 300 attendees on the
latest of those audiocasts. We will be having more programming and audiocasts
to be conducted yet this summer.

The NPI Subworkgroup also in concert with the NPIOI Workgroup helped to host
the NPI Hearing for WEDI members in April. The WEDI Board of Directors has
reviewed and approved the recommendations from the NPI Hearing Panel and shared
that information with the NCVHS and HHS.

During the WEDI May conference WEDI conducted an NPI pre-conference session
that was also very well attended, we expect to do the same thing for the
November conference later this year.

The NPI Subworkgroup is also developing an NPI assessment tool that’s
expected to be released soon and again Walter is going to provide a little bit
of information relative to the status of that.

In addition to all of the work being done through the WEDI SNIP Subworkgroup
and the NPIOI Workgroup WEDI has also conducted those NPI Hearings as I noted
earlier in 2006. The NPI has been a very hot topic for many WEDI members and
WEDI historically has been able to extract a lot of useful information from the
health care industry stakeholders by conducting industry hearings in a similar
nature to the hearings conducted by the NCVHS. The WEDI HIPAA readiness
hearings were a resounding success and WEDI leadership felt the need to conduct
a special hearing solely focused on the topic of NPI. Patrice Kuppe of Allina
Health, Marian Reed of McKesson, and Terry Christianson of Mutual of Omaha
co-chaired the effort and in addition a cross section of WEDI NPI expert
panelists participated including representations from the NPI Subworkgroup and
the NPIOI Workgroup.

Now I’d like to turn it over to Walter Suarez who’s going to provide
additional details regarding WEDI’s NPI Initiatives. Water.

MR. SUAREZ: Thank you, Mark. Mr. Chairman, members of the subcommittee, it’s
a great pleasure to be here to talk about this topic of the National Provider
Identifier, I will be using slides and I will be talking about two major
topics, the first one is a summary of the results of the 2006 WEDI NPI hearing
and the second topic will be an overview of the different initiatives that WEDI
has taken on related to the NPI. In addition to be the president of the
Institute for HIPAA and HIT Education and Research I also serve as president of
the Public Health Data Standards Consortium and co-chair of the WEDI SNIP NPI
Subworkgroup that Mark mentioned as well as co-chair of the WEDI NPI Outreach
Initiative Steering Committee, probably the two most significant efforts by
WEDI on NPI issues.

The first topic which is the NPI hearing, what I will be covering, and I’m
slide number two, is basically a very quick overview of the hearing purpose and
the process itself that WEDI followed, and then the highlights of the findings
and recommendations on five different topics, enumeration, NPI enumeration, NPI
dissemination, issues around transition, testing and usage of the NPI, and then
evaluation and understanding of where things are with NPI implementation, and
finally a few points about education and outreach.

Slide number three talks about the purpose and process of the NPI hearing,
the main purpose was twofold, identify issues related to the NPI implementation
process in the industry, and then begin to develop recommendations both to
government and to the industry with respect to ways to address these issues.
The hearing along with all the other activities that WEDI is involved with and
spearheading related to NPI are very consistent with the role that WEDI has as
an advisory body to HHS on HIPAA implementation issues. And the goal ultimately
of this hearing was to understand again where the industry is to see how we can
best meet the compliance date for HIPAA NPI.

And it was interesting that the
hearing was held actually exactly one year and one day before the compliance
date of May 2007, May 23, 2007.

The process that we followed with the hearing, there was a public notice
that was published of the hearing and was issued inviting industry to provide
and participate with written and oral testimony to WEDI. Specific topics were
asked by submitters to be addressed in the submissions in their written
testimony and in their oral testimony that included these major topics I
already mentioned, NPI enumeration, transition, testing and usage, NPI
dissemination, industry awareness and readiness, and NPI benefits. WEDI NPI
hearing panel reviewed then all the written testimonies and invited a series of
organizations to present oral testimony which was held actually April 18 which
was really a year and a few more days before the compliance date.

The hearing also allowed for interaction with the panel members as well as
the audience and discuss some of the points that were being brought up by the
presenters. Later then the hearing panel, the members of the hearing panel
summarized the findings and recommendations and submitted those to the WEDI
Board for review and approval, and then those were submitted as findings and
recommendations to the Secretary of Health and Human Services and released in a
report along with several testimonies on WEDI’s website.

Participation was pretty good, we received written testimony from about 41
organizations and oral and written testimony from 24 organizations. We had 150
attendees at the public hearing itself. Representation across the board was
very good, about 40 percent of the respondents and participants were from
health plans, about 30 percent providers, and about ten percent government, ten
percent professional associations and another ten percent of clearinghouses and
vendors. Of course some of the professional associations were representing very
large groups of providers so we had a good mix of perspectives in this hearing.

In the next slide you see the NPI hearing panel members, again counting
across several of the different sectors of the health care industry.

And now to findings and recommendations, the first set of findings relate
again to the NPI enumeration and these ones are going to be focusing on this
particular topic. The first point I think that was heard throughout the hearing
was the lack at that point of the ability of organizations to enumerate in
bulk, to use bulk enumeration or also known as EFI, electronic file
interchange. The lack of that capability was certainly making some delays in
the ability for large organizations to enumerate large numbers of individual
providers. And the recommendation was for CMS and NPPES to have a functioning
EFI process available by June 15, as a note and sort of an update I guess CMS
released the EFI instructions in May 1st and started the process for
EFI in June and as I understand it as of now about 15,000 providers have
already taken advantage of this and have started enumerating this way so it’s a
pretty big increment.

The second issue was some concern around the understanding of the way NPPES
validates information in the collection of information from the application to
obtain an NPI. I think the concern was that more of the lack of understanding
of how this validation is done, what data elements are validated, and the
recommendation was for CMS and NPPES to make available more information about
this validation process, and we set that, hopefully a date by June
15th to have that information available to the industry.

The next slide talks about a third element on the NPI enumeration findings,
confusion on the enumeration and use of NPIs by individual providers, or the
so-called Type 1 providers, and organization providers, the NPI that are Type 2
NPIs, in the administrative transactions and the lack of clarity around this
whole concept of enumerating subparts, components of organizations. This has
certainly continued to slow the provider enumeration process in many respects
and one of the recommendations was that CMS in its role as regulator of NPI
activities should certainly make efforts to provide more clarity and further
guidance on how providers should evaluate the enumeration of subparts, not just
from the perspective of the Medicare program, CMS in its role as the
administrator of Medicare, a more wider approach and understanding of how
subparts need to be considered. WEDI at the same time has recognized this as a
major issue for the industry and is continuing to work both with CMS and the
industry to try to understand better and provide more guidance as well.

Another finding of the hearing around this area was some issues with respect
to how the actual website that is used to allow providers to apply for an NPI
works and so there was some specific recommendations provided on some
improvement areas that the NPPES website could consider.

And the next slide talks about another concern on the NPI enumeration and
that is the concern around what we call atypical service providers, or ASPs.
Now just as a reminder our providers will not be eligible to obtain an NPI
because they are not considered to be, or do not meet a definition of a health
care provider. And this certainly affects all payers not just as originally
perhaps was believed, only Medicaid programs, this does affect every payer. And
it presents the same type of challenges and issues that the industry faced
before NPI and it’s the kind of area where even though we now have a solution
for health care providers, and that’s called NPI, there is a pocket of other
providers of services that are not being addressed and so we’re recommending
that CMS work with WEDI and the industry to try to develop a national
enumeration strategy for atypical service providers that would either by
exploring mechanisms to allow the use of current provider enumeration systems,
the NPPES, or by developing alternative one that do the same kind of principles
applied to the National Provider Identifier.

The next slide talks about the first of the issues around the second major
area that we addressed during the hearings and that is the NPI dissemination
and what we call the NPI information exchange area. And certainly the single
most significant issue identified in the hearing was the lack of the NPI
dissemination policy or notice, soon to be published by CMS. This continues to
and has created uncertainty on how our organizations are expected to plan and
consider accessing the data that will be available via NPPES, the data that is
collected in the process of providers applying for an NPI. And certainly has
also delayed the ability for the industry to collect that data and the need to
populate crosswalks which are necessary and critical components in the
transition process for NPI. So we recommended that CMS and NPPES move into
issuing very, very quickly, by June 15, was recommended back then, the issuance
of the NPI dissemination notice and having an operational dissemination system
in place.

WEDI will be convening a policy advisory group to assist the content of this
notice upon its publication against a report that was submitted to CMS and to
the Secretary with a series of recommended principles on NPI dissemination. And
specifically the ability of the notice to meet specific elements, the seven
elements that we highlight in this slide, when the data will be available from
NPPES, who will be able to access the data from NPPES, what data elements will
be available to be accessed, how will the actual data be able to be accessed,
what are the purposes for which the data will be permitted to be obtained or
accessed from NPPES, and then what are the restrictions that will be imposed on
organizations receiving the data with respect to their ability to use and
disclose or redisclose that information. And then certainly finally the cost
associated with the ability to access NPPES, there will be charges and costs
associated with that, what will those be.

The second item related NPI dissemination relates to the need to access
NPPES data to obtain referring and ordering NPI information, and this is the
NPI of the physician or the provider that is doing a referral to another
organization or another provider, and the ability to do NPI verification. Our
recommendation was to CMS should allow health care industry participants to
conduct simple query capabilities or implement or establish within the
dissemination of data from NPPES an ability to do simple query capabilities by
using elements such as the EIN or the Social Security Number, not that the
NPPES will release the number but that organizations searching for an NPI for a
particular provider be able to enter elements such as the EIN, SSN, or legacy
ID.

We also recommended that NPPES should allow the data to be accesses in an
interactive and quick respond mode for single NPI queries in addition to the
ability to do batch queries against the data. This in a manner similar to what
providers are very used to today which is accessing the UPIN number for other
providers that are referring patients to them so that they can include that
UPIN number in a health care transaction, in a health care claim for example.

Another concern was the concerns about the paper verification requirements
of NPI and here the concern was within the industry and with the industry that
the health plans are beginning to require as a way to confirm if you will or
verify the actual NPI that was issued to a provider, there’s only two
mechanisms known to be able to be done, one is for health plans to request that
the provider submit some verification form, or a copy of the paper, or the
notice that they received from NPPES, and the other mechanism is actually using
dissemination data from NPPES itself which is not available.

So health plans are faced with the need to consider beginning to collect and
request every single provider that they have in their networks to submit a
piece of paper or a copy electronically of their form that they received from
NPPES when they applied to an NPI. And now you can imagine if you are a
provider having 150 different vendors, or health plans, that you do business
with, having to communicate or send this paper to all of them creates a major
concern. So there is a need to find an appropriate balance and the
recommendations coming out from at least in this point in the WEDI hearing was
that health plans should at this point not require or continue to require the
submission of these paper copies to confirm or verify the notification of an
NPI.

Then another point on the dissemination and information exchange area is the
lack of standards for NPI information exchange within the industry. Now to
distinguish NPI dissemination from NPI information exchange what we consider
NPI dissemination is data that is being, or will be in the future, extracted or
accessed from NPPES versus NPI information exchange which is data that is
exchanged between trading partners, a provider sends their NPIs to the payer. A
payer shares the NPIs over their network with other payers, those kind of
internal, not internal but trading partner type of exchanges.

So with respect to information exchange there is a lack of standardization,
right now every provider is having to look at, and every payer is having to
establish different mechanisms with different standards to collect NPIs from
providers, again building upon the fact that we don’t yet access to the NPPES
database. So the recommendation is for WEDI to develop industry standards,
recommending industry standards for the NPI information exchange processes
between providers and plans, and then also recommending health plans to allow
the use of multiple mechanisms, all of them using these recommended standards,
for providers to communicate their NPIs to them. And finally we recommended
that CMS should support this type of standards as well.

A very quick update, we are in the final phase of submitting the recommended
standards on this particular area, the NPI information exchange, and we’re
hoping that within the next week or so we will be completing the process and
issuing the recommended guidance on this particular exchange.

I want to emphasize and I can’t emphasize that stronger is the fact that
this is a major element in the implementation transition process, this ability
for providers and payers to communicate, and others, to communicate their NPIs
in light of the fact that we might not see access to NPPES data until down the
road several months.

Now with respect to transition, testing and usage, the third major area in
the findings, the industry we believe is, and it was evidenced by the
testimony, is behind in obtaining, sharing and using NPIs. We continue to see,
or at that point we were seeing very low numbers of NPIs issues, even lower
numbers of NPIs being communicated back to the trading partners, providers
communicating it to payers and others, and even yet lower numbers in the
single, or even less then single digits if you can have that, being used on
electronic transactions and other forms. So really there is a delay in that
process of obtaining NPIs, sharing those NPIs, and using them.

Reasons may vary from a number of areas, lack of provider awareness and more
importantly in our view now urgency of providers to obtain an NPI, the lack of
urgency of providers to obtain an NPI. Confusing about enumeration needs,
strategies, what to enumerate, what not to enumerate, challenges to enumerate
large numbers of individual providers, now that we have EFI that might be
helping quite a bit in that area. Confusion about how to use NPIs in
transactions, there’s still questions about where in the transaction, how in
the transaction this NPI should be used. And delays in the NPI dissemination,
again, as part of the process of being able to obtain NPIs and begin using
them. Major concern exists around and about having adequate time remaining for
testing an NPI transition, and avoid potential financial risks.

So that’s one of the probably most significant findings out of the hearing
is this recommendation that I’m about to make that WEDI is moving forward and
submitting, CMS should allow the dual reporting of NPIs and legacy IDs after
the deadline of May 23, 2007 for a minimum of six months. We believe that at
least six months are needed in order to be able to achieve full compliance and
eliminate the use of the other legacy IDs which are not going to be permitted
by the NPI rule. And we might need even more then six months depending on where
we are in several of these areas, enumeration, NPI dissemination from NPPES,
and we will be looking at how the industry is doing later in November, December
of this year to assess this recommendation.

This six month period I want to emphasize is a transitional period and
transitional means here that the NPI will continue to be required in several
ways but that the legacy IDs will be allowed to concurrently be sent as
secondary IDs in these electronic and paper transactions. Now this should not
be perceived by the industry or by regulators as a delay in the actual
implementation plan itself, which is the deadline May 23, 2007, there’s three
conditions that we recommend be still maintained with respect to compliance.
The first one is providers must still have to complete their enumeration
process by the deadline, meaning the deadline to obtain NPIs is still the same,
May 23, 2007. The system remediation process must still be ready to be done and
completed by then and health plans must still be capable at that time, or by
then, to process NPI transactions.

Extending the dual use period is only intended to allow trading partners to
address NPI crosswalk mapping and reimbursement issues that might occur because
of the delay in the enumeration process. I think just to highlight one of the
challenges with this particular NPI rule that has happened because of the way
the deadline worked is that the deadline works for both providers and payers,
it’s the same deadline, and that creates the situation of certain and many
providers potentially waiting until the last minute to obtain their NPI because
it’s not required until the next day. Rather then having a deadline for
providers to obtain the NPI and then a transition period to allow the NPI to be
used and transitioned into the transactions, and after a certain deadline or
date then stop the ability to submit the legacy IDs.

One of the recommendations on transition, testing and usage, entities unsure
of implementation strategies and so WEDI will continue to identify and
disseminate best practices to industry now that there is “early
adopters” of NPI, even though we’re only six months or nine months before
the deadline, so we will be documenting and presenting those to the industry.
Lack of a central repository to track payer readiness, challenge is to
providers and others to understand where payers are with respect to their
readiness and so we’re recommending that CMS support and endorse the creation
of an industry portal that serves as a central place to track payer transition
dates and other readiness information.

Need to ensure planning is done to use NPI in all HIPAA transactions, not
just in the primary transactions like claims and claim payment. And WEDI will
be working with the industry and CMS on this issue as well.

Uncertainty on how to handle transactions when NPI, EIN, or SSN of the
referring provider, or ordering provider, is not known by submitters, there’s
still confusion about that and what other numbers can be used when a provider
is required to submit something in the claim that is about another provider and
they don’t know their NPI. So WEDI will investigate current and future HIPAA
transactions and companion guides with regard to this and even though we
understand and know and certainly have made available the information from CMS
with respect to this there’s a frequently asked question about this, there
seems like there continues to be questions about which numbers are permitted
and particularly whether some “certification numbers” will be
considered, legacy IDs, and permitted to be used or not permitted to be used as
it might be the case.

Confusion about NPI transition and use in new claim forms, the paper claim
forms, we’re recommending that NUCC and NUBC support education efforts to
providers about the new claim forms and the use of NPI in those forms. And I
think both NUCC and NUBC are doing an incredible job in communicating this type
of information so I think this confusion should begin to be addressed in the
process of informing providers on how to use the NPI in these transactions,
paper transactions.

All health plans should follow at least Medicare’s lead to require the
submission of NPIs on paper claim forms, we all know paper claim forms are not
subject to HIPAA and only the business relationship between providers and
payers is one that determines whether an NPI will be required to be used on a
paper claim. Some payers such as Medicare has established that as a requirement
and other payers are following and we’re recommending that all payers consider
doing that.

The concern that health plans might require providers to reenroll after NPI
enumeration certainly has been a big question and a concern, the fact that
there might be an intent or an expectation that because of NPI providers are
going to need to reenroll and recertify with their health plans. I think health
plans are and should continue to communicate to their providers their
requirement with respect to that and in many cases the fact that there’s no
requirement to really reenroll.

This is with respect to the fourth area, evaluation, concern that HIPAA and
other regulations are published without a roadmap implementation schedule. I
think its been proven particularly with this rule the fact that this process of
transitioning the whole industry in one single day is, even though there’s a
two year transition period it’s creating some challenges and it has been the
case in previous regulations as well so the recommendation is that CMS should
assist WEDI in creating a plan with clear planning, testing, and implementation
milestones for future regulations related to HIPAA standards.

WEDI will work with CMS to provide education and benefits and return on
investment on the adoption and the implementation of NPI, which is another area
that needs more information about. And WEDI will work with CMS, certainly
continue to work with CMS to identify potential future uses of NPI beyond the
HIPAA transactions such as the use of NPI on EHRs, RHIOs, public health, other
activities not required by HIPAA.

With respect to education and outreach, I think education and outreach
continues to be an essential and fundamental component in the successful
transition and implementation of NPI and our recommendation is that CMS
continue to partner with WEDI to provide a strategy and a plan to expand the
current education and outreach initiatives. CMS we recommend should consider
hosting monthly open door forums on NPI and promoting them along with other NPI
outreach activities throughout the industry. We also recommend that CMS
continue to partner with WEDI in establishing common outreach and education
strategies, priority messages and I’m pleased to see that we have achieved a
major milestone I’ll talk about a little later, and recommendation also is
related to CMS participating and supporting and continue to support
developments in NPI white paper documents produced by WEDI.

Another recommendation is the industry need for clarification on the
relationship between NPI and taxonomy codes and the use of taxonomy codes by
payers, providers and others in the administrative transactions. CMS we
recommend should collaborate with WEDI to provide guidance on the use of these
taxonomy codes, the when and how to use them and what to do when there is more
then one taxonomy code per provider. And we also recommend that NUCC work with
the industry to actually establish definitions for many taxonomy codes that are
yet not containing a definition into it.

Industry needs to monitor industry readiness, that’s an important element on
the education and outreach, WEDI will continue to monitor that and we plan to
look at conducting additional industry readiness assessments as the one we just
completed, and we recommend CMS should continue to partner with WEDI to provide
regular updates to the industry in different venues.

MR. REYNOLDS: Walter, could I do a process check with you? It’s about 9:41,
so we’ve been going for a while, we only have until 10:15, we want to make sure
that, you’re putting a lot of recommendations and a lot of things before us so
I want to make sure we have enough time to discuss it and it looks like you’re
about halfway through your slides —

MR. SUAREZ: The next up is very quick, I will move along. The next part is
really a quick review of the WEDI NPI initiatives and the first, the three
elements that we wanted to highlight are the WEDI NPI Policy Advisory Group,
the SNIP Software Group on NPI, and Outreach Initiative.

Very quickly the Policy Advisory Group was established to review the
proposed rule back in ’98 and had been convened several times and again will be
convening as soon as the NPI dissemination notice gets published. This is the
group that gives the general direction to WEDI on policy issues around NPI.

The SNIP NPI Subworkgroup was established in May of 2004, it is the group
that puts together documents and issues papers around industry components of
implementation of the NPI. We hold biweekly one hour conference call and you
see the list of different papers that have been published, we have a first
round of papers published in late 2004, early 2005, we have identified and
developed a number of other second round white papers, and we are now in our
third round of white papers currently underway including several of the ones
that I think I mentioned around during these earlier slides.

And then finally the WEDI NPI Outreach Initiative, this is a major
initiative that in WEDI along the lines of the WEDI SNIP Initiative put forth
in the early 2000. Of the three types of HIPAA covered entities I think, the
slide says here, providers are the ones with the widest variation in size and
internal capabilities and the hardest to reach and thus there’s a very strong
need to continue to provide outreach to providers specifically on this topic.
There are key logical sequential interdependencies on the NPI transition from
payers making assessment and providers on the impact of NPI, providers
obtaining NPI, providers communicating the NPI to payers, you see the sequence
that if that sequence doesn’t go forward in an orderly fashion there is going
to be challenges in the implementation process.

We recognize there’s significant challenges that the industry faced in the
past with implementation of the transaction codes, privacy and security, we
came about in the development of this NPI Outreach Initiative. And the purpose
of the initiative primarily is to serve as a focal point for the industry to
disseminate and communicate and inform and make aware providers, payers and
others in the industry about planning, transition and implementation of the
NPI.

It serves as a central repository for NPI resources and very quickly the
progress report, we have established an NPI Outreach Initiative website and an
NPI Resource Center website where we are putting all the information and
documentation for WEDI and link to others. We organize, and several of these
things were highlighted by Mark, organize the first industry forum and we
continue to organize those forums, here’s a couple of screen shots of our NPI
Outreach Initiative Resource Center website. We have organized additional
industry forums, developed and started to implement a national NPI outreach
plan, we have organized NPI audiocasts, the most recent one earlier this week
on NPI and taxonomy codes attended by we believe over 1,000 or 1,200 health
professionals.

We have developed and published NPI information sheets, completed an NPI
industry readiness assessment project, I wanted to spend one or two minutes on
this one because it’s a major effort of the NPI Outreach Initiative we just
completed. The purpose is twofold, is to assist the various stages of readiness
among the industry of NPI readiness and to establish a baseline to monitor
industry progress towards NPI implementation and compliance. We received well
over 700 responses, almost I think 800 responses on this, from various payers,
providers, vendors, and we’re currently completing the analysis which will be
released officially at the upcoming NPI industry forum, the WEDI NPI industry
forum.

But just a couple of highlights, the most significant findings of this I can
summarize perhaps in three areas, one is there is still a lack of understanding
of enumeration and a lot of providers and payers have stated, in fact a lot of
providers have stated in the results that they have not yet even implemented or
developed a plan for transitioning to NPI, that’s one of the major findings,

A second one is a sense that there is a risk of not meeting compliance date
and several of the findings point to that particular point in the results. I
think the industry is now beginning to realize that NPI transition will somehow
need to be permitted or continue after May 23, 2007.

And perhaps a third finding is the need to find ways to increase the urgency
among providers and the understanding of those providers of how to implement
NPI, obtain NPIs, share the NPIs and begin using them.

We have also a few other progress report activities, you see them in the
slides here, prepare WEDI testimony for the NCVHS forum back in April, or the
NCVHS hearing, I’m sorry, and work with WEDI and the NPI hearing itself. And we
have several upcoming events and activities, I think Mark highlighted several
of those.

So let me finish with a few challenges and opportunities. We believe
providers have heard about the NPI, we personally, we in general believe that
most providers have probably heard about the NPI. We believe that actually
because of the many messages they have heard and seen from different sources,
they have heard it. Why aren’t more providers taking any action? Well there
might be several reasons, probably the most significant ones are most do not
see it as a top priority yet, the deadline is still kind of a year away, some
of them believe perception that it’s only a new number, ease of applying and
obtaining the NPI, it takes four minutes to apply, four minutes to receive it
back. Those are the kind of things that make the urgency part critical.

Some are still confused about who or what to enumerate, some were waiting
for the EFI, now it’s available, and then some have not yet even heard about
the NPI, we believe it’s a relatively small number. The other thing I think
many of them are implementing plans to transition to NPI, some are already
collecting NPIs and accepting transactions with NPIs and most are waiting for
the NPI dissemination to be able to access data to populate their crosswalks,
have communicated basic information to providers, most of them, so in general
the payers are moving along with the implementation process.

Clearinghouses and vendors the same thing, in many respects, modifying their
internal systems, performing system upgrades and then waiting for payers and
for providers to be ready to submit and receive NPI.

We believe there are three ways of measuring performance and achievement of
outreach goals, the first one is the number of NPIs issued and where as we know
now passing the 900,000 mark of an estimated 2.3 million Type 1 and Type 2
NPIs, we’re not sure whether all of the NPIs belong to covered providers,
meaning providers that actually need to have an NPI, many of them might be
small individual providers that are not required to obtain an NPI, they just
are eligible and wanted to have an NPI. And the total number of NPIs might
actually be a little higher then the estimates 2.3 million, some higher
estimates put it in three or three and a half million number NPIs total.

Now the weekly rate has progressively increased and in the last few weeks I
think the NPPES system as it was reported has significantly increased to 20,000
to 30,000 NPIs per week and we hope that this will continue to be maintained
and even increase if we expect that when you estimate the number of weeks
remaining we can reach the 2.3 million or more then is needed by May of 2007.

The second indicator of achieving of outreach goals is the percentage of
NPIs communicated back to health plans and trading partners, a much lower
number, sometimes in the low single digits, like one or two percent, or in some
cases ten or 15 percent of providers have communicated NPI to the health plans
or to their trading partners. And then an even lower number is the percent of
NPIs actually used in health care transactions, very, very few of those are
starting to happen.

We believe we need to continue to focus on the top sources of information to
providers and expand the coordinating of efforts through professional trade
associations, health plans, CMS, Medicare, Medicaid, and other vendors and
others. And continue to leverage best vehicles of communicating that through
list serves, newsletters, websites, you see several of those.

We believe professional associations, health plans, should consider their
launching their own get your NPI campaigns and consider implementing something
like the NPI message of the month or something like that, very, very important
we believe, messages need to intensify in frequency, more importantly in
urgency, of the content of the message to providers, need to make sure that
providers know that they need to obtain the NPI, get the NPI, share their NPI
and use the NPI now.

For payers we need to see that they communicate their plans to providers on
how they plan to collect NPIs, how they are transition, and those kind of steps
that providers need to know about.

And then we need to continue monitoring progress, more importantly because
we need to know and understand whether the industry the industry is really
going to be able to meet and achieve May 23, 2007, as the compliance date.

Thank you very much.

MR. REYNOLDS: Okay, thank you very much to both of you, since we have
Justine and Jorge on the phone, I can’t see their hands very well, so Justine,
do you or Jorge have any of the first questions and then I’ll —

DR. CARR: Thank you, Harry, not at this time.

MR. REYNOLDS: Jorge?

DR. FERRER: Not at this moment, Harry.

MR. REYNOLDS: Okay, anybody around the table want to make any comments.
Simon?

DR. COHN: Maybe I’ll start with a relatively obviously question, we’ve
gotten a lot of slides here and I’m actually wondering what you would like from
us in terms of, I mean is the purpose of this presentation just information
sharing or was there something out of all of this that you would like the NCVHS
to do?

MR. MCLAUGHLIN: I think, Simon, it’s twofold, one is education sharing and
the second is to take a look at the recommendations that came from the NPI
hearings that WEDI held and then to make those same type of recommendations to
CMS so that we actually have action on those where WEDI participates with CMS
or where CMS needs to take action alone.

DR. COHN: I guess as I was looking through these I was trying to figure out
which ones of them had already been acted upon versus haven’t knowing that some
of these were recommendations about things that appeared to be on June 15,
2006, and other things. Are all of these still open actions that have not been
addressed or have some of them been addressed?

MR. MCLAUGHLIN: For the most part they are still open actions except for
those that are WEDI focused, WEDI is definitely moving forward with those items
that are noted as WEDI action.

MR. SUAREZ: If I may jump in, too, I think the most significant elements
here and recommendations, the recommendations are very specific and detailed
but there’s large recommendation items and probably the single most significant
one is the consideration of a transition period, I think that’s the single most
significant issue that I think this industry is going to face is this ability
to meet the May 23, 2007, deadline. We believe that we are at even at this
point ready to and have heard even from many organizations that they’re not
going to be ready, we believe that we are able to say today that it’s very
unlikely that organizations, the industry is going to be ready and that’s why
we believe this needs to begin to be considered. We believe that it needs to be
considered now because there are steps that regulatory, the regulatory process
will be required to achieve in order to allow for such a change in compliance
dates so that’s the single most significant recommendation —

DR. COHN: That’s helpful to focus. Let me just ask a question because I
actually thought that that was also probably the most important piece though I
was trying to figure out and potentially Karen or others from CMS can help me,
I heard transition, I also heard the expectation that everyone would have an
NPI by the date that is required, and really what I heard was is that there
would be a period which you would have both the NPI and other identifiers being
sent which seemed to solve a number of problems related to mappings by health
plans and other things to allow them to work, but I was trying to figure out
whether this required any regulatory changes given that I believe the
requirement is is that as of X date people will have an NPI and they will use
it in their commerce. But I may be misunderstanding that, it seemed to me that
you’re supporting that, that that date remain inviolate. Am I mistaken on this
one?

MR. SUAREZ: You are correct, I think the request and the recommendation is
that the only element in all the requirements, if I may summarize very quickly
the requirements, NPI rule requires that every provider obtain, covered
provider obtains its NPI or his or her NPI, that every provider begin using
that NPI, and every health plan begin to accept that NPI and only that NPI by
May 23, 2007. The only element we’re changing or recommending to change is the
ability to accept the NPI but also accept a legacy ID along the NPI on
transactions after May 23, 2007. We are not suggesting nor do we support at all
the idea of allowing providers to submit transactions that don’t have NPIs
after May 23, 2007, so the only element is that component of the regulation. I
believe that it will require some sort of a regulatory —

MR. REYNOLDS: I’d like to hear from both of you, I understand that clearly,
I guess if May 23rd is the date, so that’s the legislation, May
23rd is the date, second, the recommendation is that providers do
that. The third recommendation is that both can be sent in and processed which
would assume that the lion’s share of the industry is being set up to process,
to have both coming in continually, do you believe that to be a fact and at
what percentage do you think, because some people, if a number of the industry
changed their systems so that as of a certain time they’ll switch over and
they’re just going to receive the NPI then the recommendation would still put
some people in jeopardy of saying the provider has to get it and you got to
take both and what if people haven’t set it up to take both so now you got a
situation because if not everyone gets it then you got a real hole. So if you
could give us a few words on that because I’m right where Simon is, I
understand the process but there is a date.

The other thing is I would like to hear as you answer this is so if a
provider doesn’t get it, so you leave it May 23rd and so they don’t
get it, the minute they don’t get it then everybody’s in trouble because it
flows downstream to everybody else. So if your recommendation is hard stop for
the NPIs on May 23rd then my question is let’s just go with a
smaller rate, let’s go with five percent, and five percent falls right through
the cracks and what do we do, what does the industry do, how does the industry
react, how do the regulatory react, how does everybody react. So if you could
give me a few comments.

MR. SUAREZ: Certainly, the recommendation calls for that point, that every
provider that is covered by HIPAA has to obtain their NPIs by that date, just
like the rule today, there’s nothing different from that. The situation that
you point out could happen today without any change, by May 23, 2007, many
providers might not have heard of NPI or might no, so they could not obtain
NPIs and the industry will face the same situation. It will be the same
situation with this recommendation because the recommendation calls for after
May 23, 2007, just like with the rule today, no claims would be able to be
submitted or accepted by health plans if they don’t have the NPI indem(?) for
those covered providers.

If a provider sends a claim after May 23, 2007, without an NPI in the
current situation or with the WEDI recommendation that claim would still be a
problem. The only difference is that if that provider has obtained an NPI and
has not been able to test or the payer doesn’t have yet the NPI in their
records the ability to construct a crosswalk will need to be taken during those
six months that we are recommending. Because again the problem that we see is
the fact that the deadline applies for both providers obtaining the NPI and at
the same time for payers to only accept the NPI as the ID for that provider.

So I think the recommendation that a transition be allowed for an additional
six months just purely tries to do what the industry should have done between
three years ago and now that couldn’t do because there many factors affecting
their ability to do that, there is no single factor that is affecting that,
certainly there’s many factors, but many of those factors are still there and
are still making it very difficult for the industry to prepare itself,
transition, test, make sure that the claims that are received electronically
don’t fall in the cracks or get stopped. And the concern concretely is that if
that weren’t to be done many transactions after May 23, 2007, that comes with
an NPI and also with a legacy ID will need to be stopped and dropped, or
rejected.

MR. MCLAUGHLIN: Jamie Ferguson is a vice chair of WEDI and also is on the
NPI hearing panel, he wanted to make a comment as well.

MR. FERGUSON: I would like to just make what I think is a clarifying comment
about this recommendation from the perspective of the panel that received
testimony from the industry. Many payers are building their crosswalks through
a process of expecting to receive transactions between now and May
23rd which contain both the NPI and the legacy ID and so as their
providers become enumerated then they will build their crosswalks as they
receive transactions before May 23rd.

One of the issues that this recommendation is intended to address is the
fact that after May 23rd my understanding of the regulation is that
the use of legacy IDs on those transactions is prohibited therefore for
providers who become enumerated close to or immediately before the May
23rd deadline the payers then would have no opportunity to build
their crosswalks and they may be unable to pay some of those providers. So this
recommendation is intended to address the process of payers building their
crosswalks as well as intended to address and mitigate to some degree the
effects of the delay in the availability of NPI dissemination from CMS for the
building of crosswalks. So basically instead of prohibiting legacy IDs as a
hard cutoff on May 23rd or thereafter this would allow their
extension for the building of crosswalks and to facilitate systems testing by
business partners and trading partners and to ensure the flow of financial
transactions for the interim period.

MR. REYNOLDS: But it also does, but it does have a portion of your
recommendation that clearly supports a hard stop, which means that those claims
would go to paper.

MR. FERGUSON: It means I think that, I think what you’re calling a hard stop
is maintaining, in the recommendation maintaining the requirement of
enumeration by the deadline, yes —

MR. REYNOLDS: Or else.

MR. FERGUSON: Or else, that’s right —

MR. REYNOLDS: I’m just making sure I understood that, I’m not pushing back
on it. Let me let Karen make a comment and then I want to recognize —

MS. TRUDEL: That is my follow-up question as well because this makes an
assumption that by the hard stop date providers, the vast majority of providers
will have obtained their NPIs, their vendors will have enabled them to use
their NPIs in administrative transactions, and their clearinghouses will be
able to deliver those transactions to the door of the health plan, and if any
of those things isn’t correct we’re talking about a lot of paper. And so I
guess I’m wondering what input the panel heard from them —

MR. FERGUSON: We received a lot of testimony on this point and approximately
half I’m going to say of the testimony basically said that if there’s any hint
of a delay the industry will take all the additional time they can get, in fact
a significant portion of the testimony requested as much as a two year or
longer extension of the rule outright. However it was felt by a majority of the
testimony that was received that maintaining a hard stop deadline would ensure
industry compliance with the rule.

MR. REYNOLDS: I do not see what you recommend as the, I’ll use the word
because it’s our fourth day here, penalty, so if somebody doesn’t by May 23,
2007, so what?

MR. FERGUSON: I think in this recommendation if there’s no NPI on the
transaction then the transaction would not result in a payment, be rejected.

MR. SUAREZ: And if I may jump in quickly, in reality there’s two hard stop
dates, the first hard stop date is when can transactions contain only legacy
IDs, the second hard stop date is when transactions after they start containing
NPI and legacy ID have to stop not containing the legacy ID. There’s two hard
stops, they are insisting that the first hard stop, that transactions only with
legacy IDs be retained by May 23, 2007. We’re just requesting or recommending
that the second hard stop be moved to sometime later because that ability to
send a claim with the NPI and a legacy ID at the same time is what allows
payers to build the crosswalk, make sure that the provider that’s submitting
the transaction is the provider that they need to pay to, and to process the
transaction correctly internally and that’s the period that we believe we’re at
risk.

DR. STEINDEL: I still have my follow-up, Harry, because I don’t think they
addressed part of your question, they did clear up one thing in my mind, what
purpose would this serve, but from what I gather people are now developing
systems both at the billing software level and at the payer level to receive
this information, to receive an NPI. They are not building billing software or
systems to receive this information at the payer or clearinghouse level to
receive two ID numbers. So as Harry pointed out earlier we now probably, if
this recommendation was put into effect they’re going to now have to reconvert
all the work that they’re doing and we have what, less then a year to do that
and testing, etc., it seems to me that we should just go ahead and do what we
is stated in the law without introducing this new level of cost.

MR. SUAREZ: I think everybody, providers, payers, and clearinghouses and
vendors are building their systems to do two things, during a transition period
accept both the NPI and a legacy ID, they’re not just jumping from today it’s
only legacy IDs, tomorrow it’s only NPIs, they’re building their systems to
allow the transactions to come in with both and that’s really the most critical
transition step. A clearinghouse today is changing its programming to allow
that in a claim that comes in the coding in the claim either comes with an NPI
and a legacy ID or with an NPI only or with a legacy ID only for that matter.
So the systems are being built to allow that capability.

MR. REYNOLDS: I guess my question is is that, was that a unanimous
discussion from your hearings or back to my earlier point, and I carefully
worded my earlier point, whatever percentage is not is somewhat adrift based on
what the recommendation is.

MR. FERGUSON: I understand that, there is a dual use strategy in effect that
has been widely accepted by payers, I don’t think it’s unanimous acceptance,
but it has been widely accepted by the vast majority of the payer and
clearinghouse community that was represented in our hearings and I’d like to
refer to the subcommittee and perhaps provide a copy of the WEDI white paper on
the dual use strategy to further explain that.

DR. STEINDEL: I can understand a dual use strategy where they could accept
either number and doing software to do that, but it’s not the vast majority,
it’s like Harry said, it’s got to be 95 plus percent, are they planning to
receive, setting up to receive two numbers. And if they’ve designed their
software in that case then I feel somewhat, since you explained why you’re
doing it I feel neutral on the recommendation but if they are not then I think
we have problems.

MR. SUAREZ: I would argue that 100 percent, I would argue that 100 percent
of the systems today are being built to accept not, it’s not either/or, it’s to
accept one, accept both, or to accept the other. And during the transition most
payers and most providers, and again I’m using 100 percent because I believe
there is the level of consensus around the fact that in order for this
transition to work you need to have the ability to send both at the same time
in the exactly same transaction. And I cannot even think of which, there might
be one or two, cannot think of anyone that has said no we’re going to jump from
only accepting legacies to only accepting NPIs.

MR. FERGUSON: And I would just add to that that we did not hear in our
hearings or in teleconferences or workgroup meetings from any payers or
clearinghouses that were not implementing the dual use strategy.

MS. VIOLA: Allison Viola from the AHIMA, just a question on the NPI
enumeration on the ASPs. You had mentioned that CMS to work with WEDI to
develop a national enumerator for the ASPs, what if any work has been done,
could you discuss a little bit about that please.

MR. SUAREZ: Thank you, yes, WEDI has produced a report, a white paper is
available actually on the NPI and atypical service providers first of all
describing who they are in general, giving some guidance on understanding what
are the individuals and organizations that generally would not be eligible to
obtain NPIs yet they still are engaged in transactions with payers and others.
And then recommendation three different approaches, not recommending but just
highlighting three different approaches.

One is we continue the current status quo of every payer continuing to
enumerate these atypical service providers on their own. Again, still creating
the same challenges that providers, health care providers have today without
NPI.

The second approach was regionally there are some regions that are looking
at organizing internally and developing a regional approach whereby one of the
entities will have a number assigned to each of these atypical providers and
then share that number with all the other payers so everybody has the same
number. I’ll give you a concrete example, interpreters, health care
interpreters, interpreters that go into a clinic and serve as an interpreter
for the patient and the provider, they bill, they actually bill in the 1500(?)
forms, or electronically some of them an 837 and they are enumerated by health
plans just like any other health, well, not like any other health, but like a
health care provider even though they’re not a health care provider. And they
serve patients and are reimbursed from payers so they have the exact same
challenge as a health care provider.

So the second one was a regional one and then the third one was this
national enumeration approach. What we found out was that given the current
structure and regulatory establishment of NPPES, NPPES has the limitation of
not being able to be used to enumerate anybody that is not eligible to a
number.

So that’s the reason we came forward saying well we need to figure out how
to either change that or develop some other alternative that is national in
nature that uses a common enumeration system for atypical providers.

MS. TRUDEL: I actually wanted to go back to Simon’s point of what the end
game was here and did kind of want to close the loop in that CMS either has
done a number of the things that are being suggested or that we continue to
partner with groups like WEDI on outreach and are happy to continually provide
additional FAQs if the need arises, etc. The data dissemination notice is not
published because we aren’t working very hard to get it published so there’s a
lot that’s still going on behind the scenes that we’re going as fast as we can
to get a lot of these things done.

And then the last thing that I wanted to mention was that we are in the
process of setting up a meeting with WEDI very shortly in response to a letter
to I believe the administrator to sit down with them and talk about some of
these things. So in terms of the subcommittee members trying to figure out what
their next steps were I just thought that was maybe useful information for you
all to have.

MS. GOVAN-JENKINS: A second part to what AHIMA just asked as far as the ASP
providers, I’m concerned if the regular providers are having, will probably
have a hard time getting their NPIs by May 23rd how hard would it be
for the ASP providers if they don’t have anything, so how hard would it for
them to even get a number?

MR. SUAREZ: This will be certainly a very significant challenge and we’re
not in the recommendation suggesting that that be done by the same May 23,
2007, that needs to go through a different process and a different approach and
it will take a long time, it will take years, it will not take months to
identify, enumerate, educate, inform and begin to have them use a common number
as providers, health care providers would need to do.

MS. GOVAN-JENKINS: So is there are a large percentage of ASP providers out
here?

MR. SUAREZ: There’s a very significant number in every state dealing with
every single program, including Medicaid as well as private payers, yes,
there’s a very large number of atypical service providers.

MR. REYNOLDS: If you can send us any information about these ASP providers
subsequent to your testimony I think that’d be helpful because that’s an arena.
But Simon, let me let you and then I’m going to close this session so we can
stay on schedule.

DR. COHN: I personally want to thank just personally WEDI for bringing this
all forward and I think it’s very timely. As I’m listening to this I’m sort of
reminded, I think unfortunately I’ve been around long enough that I actually
remember the initial HIPAA implementation so this has sort of an eerie reminder
of the 837 implementation. And obviously it’s the case whenever we get close to
the financial relationships in the industry we obviously, everybody has a major
desire to ensure that all of what works. The good news is I think we’re, what
are we now in August, this doesn’t become a fait accompli until May of next
year so I think it’s one of those things where we don’t have a lot of time but
I think that there’s some close monitoring that the subcommittee is going to
need to do and there may need to be some specific recommendations around
interventions or transition periods or whatever. But I guess I would like to
hear, I mean I think WEDI has done a great job getting the industry and getting
views, the issue is obviously is that obviously all this changes on a month by
month basis as we know and I think maybe hearing from additional payers,
clearinghouses and whatever we’ll really find out what they think the world is
on an ongoing basis from here out I think would be very useful.

MR. REYNOLDS: I think we’re starting to figure out one of the things that
will be on the October agenda, one thing I would like to ask maybe even WEDI to
come back with for that session would be when it says a hard stop in May, hard
stop kind of focused on one thing and that was providers getting their NPIs.
But if you’re talking about a transition period then you’re saying that the
transition period starts that day and so therefore I would say that you would
also have to have some kind of assurance from clearinghouses and vendors and
payers and everybody otherwise you just started another clock where everybody
could say well I just got it. So I would be anxious to hear if you would come
back, in October I would be anxious to have you vet maybe that more because
saying okay, penalizing one segment or hard stopping one segment, everybody has
got to be at some point otherwise you don’t have a transition period, you just
have the next phase of everybody grouping up again.

So thank you very much, I think you did a great job, your outreach, working
on NPI at home, thank you for what you’re doing because all of us need
everybody to get going.

Now we’ll take a ten minute break and we’ll be back at, well 10:35 we’ll be
back so that’s a 13 minute break.

[Brief break.]

Agenda Item: CHI allergy Workgroup – Preliminary
Recommendations

MR. REYNOLDS: Okay, we’re going to move into the next portion of the
presentation and it’s going to be from the CHI Allergy Workgroup and I will let
the people that are here introduce themselves and I believe there is some
others that have called in so if you will introduce yourselves, those of you
that are on the phone, and then we’ll open it to the people here to tell us who
they are.

MS. BARNES: This is Lenora Barnes, I’m one of the co-chairs of CHI Allergy
Workgroup and I work for the VA.

DR. LAM: Siew Lam, I’m part of the workgroup member and I also work for the
VA.

DR. PARRISH: This is Fola Parrish, I’m part of the workgroup but I work for
DOD.

MR. REYNOLDS: Is that it? I heard there were eight and I see five in front
of me so that adds up pretty quick. Okay, so why don’t each of you introduce
yourselves and Beth, if you want to, Elizabeth, if you want to take it first
and tell us what’s going to happen today I’d appreciate it.

MS. HALLEY: Thank you, Mr. Reynolds and Mr. Blair and members of the
Subcommittee on Standards and Security, my name is Elizabeth Halley, I work for
Mitre and I have acted as the CHI facilitator now for a bit over a year. I
would like to take this opportunity to let the members who are able to
participate in person introduce themselves, we can start with Dr. Kilbourne.

DR. KILBOURNE: I’m John Kilbourne, I work at the National Library of
Medicine, and I’m a member of the CHI Allergy Committee.

MR. HESS: My name is Bill Hess and I work at Food and Drug Administration,
also a member of the CHI Allergy Committee.

DR. LUCCIOLI: Stefano Luccioli, I’m in the Center for Food Safety at FDA,
member of the CHI Allergy Committee.

MS. SMITH: I’m Elizabeth Smith, Betsy Smith, I work for FDA Center for Drugs
and I’m a member of the CHI Allergy Committee.

MR. REYNOLDS: Well, welcome to all of you and we look forward to your
report.

MS. HALLEY: Thank you, we would just like to mention how much we appreciate,
the whole workgroup appreciate the fact that you’re having us here today, we
recognize you’ve had a very long week, a lot of the NHIN presentations, I think
we are actually the last presenter so we will do our best to be concise and get
you out of here —

MR. REYNOLDS: No, your subject is always important to us.

MS. HALLEY: Thank you we appreciate that.

The main purpose of our presentation today and testimony is about the
Allergy Workgroup work report but I would like just to take a minute if you
don’t mind and just give you a very brief update on some of the other workgroup
efforts and then we’d like to talk to you briefly about some of the
collaboration activities between CHI and the Office of the National
Coordinator, and talk a little bit about our next steps.

First the Multimedia Workgroup wanted to extend their appreciation for your
endorsement letter to the Secretary of HHS endorsing their recommendation for
DICOM, so thank you very much for that effort.

As you had requested I wanted to mention a revised report recommendation
that has come to us, it was presented to the CHI Workgroup last month by Jim
McCain from the VA who is very active in IEEE. As you know IEEE is the CHI
endorsed standard for device interoperability and the IEEE 1073 standard name
has changed, it is now known as IEEE 11073. We have made these changes to the
CHI report, we have versioned it to 1.1, and upon bringing this to your
attention we will apply the updated report to the public website.

In terms of the Disability Workgroup I just want to give you a very brief
update that we are continuing our work, we are in the process of developing our
recommendation report that we hope to bring to you in October. And in terms of
the steps that we have gone through we have taken your recommendations from the
first NCVHS presentation of the report and are working very closely with our
federal partners at looking at LOINCifying(?) much of the disability questions
and then looking at CHI endorsed vocabularies and answering those questions and
looking at an HL7 format for transmitting those transactions. And again we will
plan and hopefully have that report to you by your October meeting.

And again the main purpose of the meeting today is the Allergy Workgroup
standard recommendation reports. The workgroup has asked that I go through
these slides just to present the overview of the recommendation, it should not
take too long, and we would like to give you the opportunity to ask our subject
matter experts that are both in person and on the phone any questions you may
have.

The Allergy Workgroup started its work about a little over a year ago
actually in May of 2005, it was brought to CHI as one of the important federal
needs for interoperability, and this has also been recognized outside of the
federal enterprise as I’m sure as you are well aware with the IOM report and
several of the concerns about transmitting allergy information. I believe the
2000 IOM report stated that 12 percent of the medication deaths are related to
medication allergies that were actually known at the time. So the workgroup
recognized that this is a very, very critical information need for
interoperability across the health care enterprise.

However, it is a very, very complex area. As you can see from our members
here there are food allergies, there are drug allergies, there are latex
allergies, there are environmental allergies, so it is a very, very complex
area and there is no standard available. So as we proceeded with our work it
wasn’t as if we could go out and say well there are four different standards,
let’s evaluate each against our criteria. Because of how complex that domain is
we really needed to look as you will see across almost 30 different
terminologies and domain areas to come to consensus on how do we identify an
allergy standard that could be used across all of these areas.

In terms of our membership, as you heard on the phone as well as in person,
the VA, DOD, the FDA, the EPA, NLM, and CMS have been very, very instrumental.
We have approximately 20 some members, 22 members exactly of the workgroup.
Some people we would bring in as subject matter experts for specific areas but
overall we’ve had about 13 continuous members participating since the
beginning.

And in terms of the process that we went through we did, we combined all of
these member, these subject matter experts and as a matter of fact we have
never met in person, all of our meetings have been webex(?), teleconference,
and that is why some of the folks are on the call today are from Salt Lake,
Florida, West Coast, and so as a matter of fact today is one of the first times
I’ve met one of our members in person even though we’ve been discussing
forever, actually two of our members, so just to give you a framework for how
we’ve worked and how our process has gone forward.

When we started the process and recognizing it was complex the way that the
workgroup kind of framed how we handled this is we looked at HL7 at the IAM
transaction which is actually an allergy and adverse reaction transaction. And
it gave us a reference for what kinds of information we needed to be thinking
about in terms of vocabulary related to allergies. We also looked at the HL7
3.0 reference information model, although the workgroup was very interested in
how it’s framed there just hasn’t been the testing of that to date. So as we
move forward today and we look at how the kinds of information and the kind of
vocabularies we’re going to be recommending it is based on the 2.4 HL7
transaction.

In terms of the vocabulary needs within the allergy domain it includes
things like the type of allergy, is it a food, is it a drug, is it a
miscellaneous allergy. The severity, when you have this reaction is it mild, is
it moderate, is it anaphylaxis, is it fatal. An allergy reaction is also what
happens to you when you have allergy, do you break out in hives, do you have
abdominal discomfort, and there is actually no standard available anywhere for
vocabulary related to the reaction.

The most complex area for the vocabularies that we considered in the allergy
transaction is actually the name of the allergen and as I mentioned before
because allergies cross so many different areas there was no place we could go
to find a standard so we had to look across things like food classifications,
drug classifications, and other types of classifications. And the bulk of the
work for this workgroup has been within these last two areas of the name of the
allergen and the allergen group, and we’ll go through each of these allergens
but I want to give you that framework. And as I mentioned we looked at over 30
potential vocabulary candidates that could support this area and these includes
CHI adopted vocabularies, some other proprietary vocabularies as well as other
non-proprietary vocabularies.

When we look at the, even within HL7 this is the allergen type as I
mentioned to you before, when you’re compiling information about an allergy you
can see, here are two that we looked at for the allergen type, HL7 and SNOMED,
and you can see the granularity of the SNOMED allergen type. The workgroup in
considering this piece of the recommendation felt that SNOMED was really the
more appropriate and more granular of the options available for allergy type.
So you will note in our recommendation for allergy type we are recommending
SNOMED.

In terms of allergy severity as I mentioned we looked again at SNOMED and
HL7, the workgroup felt that SNOMED again had a more granular ability here and
I’ll show you the last one for the categories of allergy is allergen reaction.
You will see that HL7 when you look at their transaction there is no
recommendation, it’s essentially use local codes or local values. So what we
looked at was VA and DOD through their CHDR project, which is their Clinical
Health Data Repository project, where they are sharing information across with
each other, they submitted to the workgroup a list of approximately 300 codes
that they are now sharing, that they have mapped to SNOMED for transmitting
allergy reactions. And here are just a few of them but you can get the sense of
things like angina, map to a SNOMED code and it just essentially shows you what
that SNOMED code value is. So we are recommending that the VA, DOD mapped to
SNOMED codes be adopted for allergy reaction.

So as I mentioned the most difficult and most complex area that we needed to
work with was the allergen description or the name of the allergen and the code
associated with that. As I mentioned the workgroup looked at many, many options
and they are in your report but the recommendation that the workgroup is coming
to you with is to use the FDA SRS for drug and name allergen and the EPA SRS
for all non-drug non-food allergens. And what another piece of the work that we
have been working on is a relationship between FDA and EPA such that all
substances that are related to allergens in the FDA and EPA SRSs will be
available in both substance registry systems. So this collaboration between the
FDA and the EPA has started and this is so from a user’s perspective if they
need to identify what are all the allergen names as I’m building my system or
creating an interoperability transaction they would be able to access either
the EPA SRS or FDA SRS to locate the names and the codes.

The workgroup developed and it’s also in your report and I have a copy of it
here a schematic, as you can see this is a fairly complex as I mentioned domain
and they created, the workgroup members created a schematic to help you and
anyone else who is developing a system or trying to understand this system, or
this recommendation, excuse me, how all these pieces fit together. And there’s
one addition on the schematic that is not here that came to the workgroup’s
attention and that is name brand drugs.

This is a difficult area because the UNII code, and by the way, I should
have mentioned this early on, every recommendation that we are bringing forward
to you is from an already endorsed CHI standard and one of the areas that we
recognized in allergy is the situation where a patient comes and mentions I’m
allergic to valium and doesn’t really know what the generic name of that is or
what the ingredients of that is but they will say I’m allergic to valium. We
needed a way for the systems to be able to capture that, the DOD currently
captures that and also enforced and I guess really encouraged the workgroup to
include name brand drugs as part of our recommendation. So you will see on the
schematic in addition to the UNII codes from the FDA and the EPA SRSs we are
also recommending the NLM RxNorm for name brand drugs.

In terms of the group, when a patient comes in and he might not know what
antibiotic he’s allergic to but he knows he’s allergic to an antibiotic you
want to have the ability to put a group in there the patient comes in and says
I’m allergic to antibiotics. So the group looked at several different sources
for this information and they are recommending to NCVHS that for the drug piece
it would be the NDF-RT, this is already been a CHI endorsed standard for
physiological effects and mechanism of action and the Allergy Workgroup is
going to extend this into chemical structure.

In addition they are asking that the FALCPA Act which is the Food Allergy
Consumer Protection Act groupings of food be considered. So a patient may know
they’re allergic to dairy products but may not know milk, but that ability to
group foods and the FALCPA does identify what those eight groupings would be.

As I mentioned about the schematic, I recognize this is hard to see on the
screen, it is in your report but I think, it should be in your reports, it’s in
the actual allergy recommendation report. It’s one of the appendixes, page 39
—

MR. REYNOLDS: If you saw our copy you would not be expecting us to see it.

MS. HALLEY: It’s very difficult to see and I do want to mention this for one
graphic, a tremendous amount of work has gone into this graphic, probably
months of work so I do want to recognize the folks that have really worked hard
to illustrate for you what this complex area is. And essentially it shows you
the source of the allergen, how that’s broken out, for things like we talked
about there’s drugs, there’s brand names, then there’s ingredients, there’s the
generic names, there’s biological substances, it’s a very as I mentioned a
complex area. Then we have the allergen group as we talked about or the
classification, and they are fed by different types of terminologies and that
is what is illustrated here, what the proposed terminologies are, which we just
reviewed, who the authoritative source for those terminologies are, and who
might contribute to that. Like we mentioned the Languel(?) who Stefano can
speak to is one of our food sources which will be feeding into the FDA SRS as
an example. And then it also points out the SNOMED recommendations we are
making for several of the allergy terminologies.

I do want to mention, I think it’s important to mention, that the group is
presenting this as a conditional recommendation based on a couple of activities
and I would like to go over what the group felt like the gaps and the obstacles
were and as long as these obstacles and gaps were met they are proposing that
it move from conditional to a final endorsed recommendation.

The UNII code assignment and availability. As you can see a significant part
of this recommendation is build on the unique identifier code available in both
the FDA SRS and the EPA SRS. As mentioned here it would be for things like
active ingredients, inactive ingredients, there’s dyes, over the counter
herbals, biologics, foods, environmental, and the non-food drug that we talked
about. And the group felt it was very important that these be aggressively
completed and the FDA folks that are here can certainly tell you where they are
in that process. But the furthest date that all of these components would be
incorporated into the SRSs would be December of 2008. In addition since this
effort of collaborating between the FDA and the EPA is a new process the
workgroup wanted to ensure that that availability of information in both
systems was complete and that strategy was complete and the information
available.

As you noticed from a couple of the slides we talked about the SNOMED and
HL7 versions of transactions, we have spoken to the HL7 people, they are very
interested in collaborating with SNOMED and enhancing the work that they do,
they have done to date within the HL7 allergy area. And the other piece, and
Dr. Kilbourne can speak to this as well, when we looked at all those allergy
terminologies and we mapped them and we showed you the concepts within SNOMED
there is not an allergy hierarchy, those codes that we identified actually come
from different hierarchies within SNOMED. And one of the recommendations from
the workgroup would be to work with SNOMED in creating an allergy hierarchy
that all of these codes would be part of.

In addition the group, there is updates to the NDF-RT, it should be coming
out, it is proposed for this summer, I can’t give an update to that right now
and I’m not sure if any of the VA folks on the phone can. But the group felt
that it was very important that those updates to the NDF be completed and
available through the download mechanism that any of the system developers
would have access to that information. And again that’s for the drug
classification.

In terms of next steps we would like to work with you as whatever activities
you need from us in terms of completing this endorsement of the allergy
recommendation. As I mentioned earlier the CHI Disability Workgroup will
hopefully be presenting a report to you in October. And lastly in terms of our
activities of coordinating with the National Coordination for Health
Information Technology and their standards harmonization, the last time we
spoke to you you had requested information when we were saying we were working
with them to ensure that the CHI standards were included in the HITSP standards
and to date all of the relevant CHI standards relating to the three use case
that are currently being reviewed do incorporate all of the CHI relevant
standards so I wanted to let you know that. And the CHI Workgroup has also been
asked to help with the review and testing of the interoperability
specifications which will be coming out from HITSP later on, actually the
middle of next month.

So I just wanted to give you that update from CHI and some of the
collaboration activities we’ve been working on with HITSP, ONC, and also the
NHIN which I know you’re probably much more familiar now with.

That concludes our presentation and I’m happy to have any of our subject
matter experts respond to any of your questions.

MR. REYNOLDS: Well first I’d like to see if anybody else on your team has
anything to say before we go on since there’s some on the phone and some here.

MS. HALLEY: This is not usually a quite group —

MR. REYNOLDS: Justine, make sure I acknowledge you, is there anything you
wanted to ask before I turn it over to hands that I see in the room?

DR. CARR: No, I found it very interesting but I don’t have any questions at
this time.

MR. REYNOLDS: Judy and Wanda, did you have anything?

DR. WARREN: I had a question about slide nine, I just want to be sure I
understood what was on there. You talked about a VA/DOD map to SNOMED, will you
clarify, is there a terminology that VA/DOD has and you’ve mapped SNOMED and
you have gaps or just clarify that a bit.

MS. HALLEY: Yes, and Lenora and Fola, I know you’re on the phone, I will
attempt, Nancy Orvis from DOD has joined the call as well. Yes, on slide six
actually we show the, this is an area, allergy reactions, that there was no
available standard to even consider, HL7 did not have one and as I mentioned
there is no real allergy hierarchy within SNOMED but because VA and DOD are
currently sharing this information they have created this list of allergen
reactions and they have mapped it to SNOMED. And with that I have slides, for
those of you that are on the telephone I have slide six up which just
demonstrates the top four, or the first four actually, of the 300 codes. And
Nancy or Fola or Lenora, if any of you would like to respond?

MS. ORVIS: This is Nancy Orvis. Just realize that we both had health care
systems and because there was no existing terminology we combined the terms
that we had both needed respectively on our own systems, that’s where we got
our list from, and then we mapped them to SNOMED. I mean that’s the simple
answer for what you see there on nine.

DR. WARREN: And so were you able to, like you have 100 percent coverage or
80 percent?

MS. ORVIS: As we said combined we had about 300 terms and we harmonized that
to the 300 terms and I believe Fola or Lenora, I think we got a SNOMED term for
all those 300. Is that correct?

MS. BARNES: Yes, we did.

DR. WARREN: So what you’re proposing is to take this list of allergy
reactions and use it as kind of a grouper and to propose that back to SNOMED?

MS. ORVIS: As a starter set of reactions, basically we’re proposing this as
a grouping now to SNOMED.

DR. WARREN: Okay, that clarifies it, thank you.

DR. KILBOURNE: I just have a small comment on that, I think it’s helpful to
look at this as a subset as much as a map and these terms are distributed
throughout SNOMED in different hierarchies and I don’t know that SNOMED would
necessarily put them all into one hierarchy, they may do that, we could look at
this as a subset of SNOMED and talk about the subset, the allergy reaction
subset. It doesn’t really, it’s not published yet but if and when it is
published and distributed then others will have access to it.

MS. ORVIS: And can I add for the committee, the importance of that is any
vendor creating an application needing to call up a set would find it much
easier to go and pick a hierarchy and use that in their application development
then they would saying you have to find these 300 terms scattered around the
SNOMED.

DR. WARREN: And that’s precisely why I asked the question because I think
it’s a great idea —

MS. ORVIS: We definitely were very much oriented to what you needed to get
allergies working with real time vendor systems, I think the work that DOD and
VA was doing was heavily driving to that because we realized how much we would
have to map manually if we could not get that set clearly delineated, because
you couldn’t go and buy new applications with something on allergies and tell
the software vendor to use that very easily unless you were able to write a
specification very clearly.

MR. REYNOLDS: Do you have a follow-up? Jeff?

MR. BLAIR: I’d like to express my personal appreciation for the work that
all of you have done in this area, I think the fact that you had to go to so
many different coding systems to be able to a comprehensive job is a reflection
of how much work was needed on this and it took time and apparently a lot of
cooperation and I think this is a significant effort. So my question gets to
the reality of what you had to compile to come up with a meaningful
recommendation and structure, it’s complex, it includes a lot of different code
systems, and I think it’s very important and very valuable, implementation
probably will need guidance. Could you share with us maybe what plans you might
have for creating some type of an implementation guide for folks that might be,
might need to implement these, this structure, instead of calling it a code
I’ll call it a structure, or maybe you have a better term —

MS. HALLEY: Complex structure, yes. Mr. Blair, that is an excellent question
and as you know within CHI the three main efforts that CHI was initially
charged with was coming up with the recommendations for the standards,
harmonizing those standards where needed as identified here in the gaps area,
and the third part was developing implementation guidelines. And in some of our
areas, and we have presented some of those implementation guidelines to this
group, however with the development of the HITSP process CHI, the CHI process
will be transitioning into the HITSP process and it will be within the HITSP
process that the interoperability specifications will be coming out at the
national level as opposed to the federal level.

And that being said the HITSP Consumer Empowerment Technical Committee,
which is looking at the PHR standards, has contacted us and based on the
thoughts of this committee have asked that we present this recommendation to
them as early as next week as they are beginning, they are actually in the
process of developing interoperability specifications and since as we mentioned
earlier there is no other standards available for allergy and it is such an
important piece of the health information that based on the recommendation of
this committee we would, we’re proposing to actually take this, even though
there are pieces and we recognize that are not complete and present this to the
HITSP group as early as next week.

MR. BLAIR: You could tell, I’m actually excited about what you’ve done
because it’s not just simply going out and looking at what’s already been
developed in terms of a code set, finding which is the best one and saying this
is the best one. What you’ve actually done is you have added to the body of
knowledge, you’ve created a foundation upon which allergy can be better
understood and which work could begin with based on this foundation. And I
believe that that’s true from what I’ve heard. So my next question gets to
something frankly it’s a little beyond the scope of your coming to us and
asking whether we would concur with these recommendations and I would certainly
say we would.

One of the things that occurs to me is that with this foundation that you
have laid it begins to allow us to explore and identify the relationship
between these different allergens and immunization levels, and I’m only saying
this from my personal situation, I had my immunity system completely broke down
about 20 years ago and it took three years for me to rebuild it so I have a
real personal appreciation for trying to understand not only what allergens
your body responds to but in terms of being able to understand it well enough
to understand what are the core ones so that you could rebuild your immunity
system.

And you’re providing that foundation so I’m wondering there’s any derivative
work, any related work, that is being planned to build upon this foundation
that you’ve laid, to use it to learn more about the progress of how people lose
their immunity systems and how they could rebuild it.

MS. HALLEY: I am going to open that up to our subject matter experts, it’s a
really fascinating question and we have lots of experts here so I would like to
call on some of them if they had any thoughts about that question.

DR. LUCCIOLI: It’s not something I think we talked about specifically but
that’s a very interesting point. I can elaborate a little bit on foods in that
I think foods too are starting to gain a lot more public perception of problems
and one of the I think not something that we have talked about in this group
but something that’s going on in our center is developing a product, or
identifying food products, this CHI allergy recommendation is focusing on food
substances but we realize that a lot of people don’t know what the substance
they’re allergic to is, they’re reporting I ate this food or I ate this
product, so we’re trying to correlate, get a better understanding of products
so that we can correlate the substances to those products. But I don’t know if
that answers your question but in terms of going into the science of the
immunity —

MR. BLAIR: It’s beyond your scope of what your mission was, sure.

MR. REYNOLDS: Stan, I think you had a question? Would you introduce yourself
since you weren’t here when we first started.

DR. HUFF: Stan Huff from Intermountain Health Care and the University of
Utah, member of the committee and the subcommittee. There’s a lot of complexity
here and you’ve illustrated that by the slides and the, I guess it goes a
little bit towards what’s the next step in terms of an implementation guide
because as you point out the thing that you want to end up with at the end of
the day is to know if we’re given HL7, whether it’s HL7 or some other kind of
message, when you have an allergen field what’s the set of allowed codes that
goes to that field and I might have missed it but I didn’t see that yet in what
you’ve produced here but I assume that’s the direction you’re going.

It points, your slides point out some of the trickiness in this in that if
you consider the HL7 message where it says allergen it’s expecting then you to
say the name of a substance of something else but you have all of these codes
in SNOMED that say allergy to, which by adding those words makes it a finding
rather then making it a substance. So all of the codes that say allergy to you
might think those help you but in fact what they do is sort of confound things
because what you’re really looking for is a subset of substances rather then a
subset of things that are findings where you’ve added that word. So anyway, it
just, I’m grateful for your work in this area and I look forward to that next
step because there’s again a lot of complexity here and it’s a very important
area to get some interoperability around so that these things can be shared and
we can provide better patient care.

MS. HALLEY: May I make just one comment if I may? That’s exactly the
approach that the workgroup took when we looked through the HL7 transaction and
I don’t want to mislead the group if in fact in case we may have but in terms
of the allergen group name and the allergen code this workgroup is recommending
not SNOMED but the UNII code, the FDA UNII code for those particular fields,
and that in fact is the most complex area which took months and months of work
within this group to really come up with that particular recommendation. For
SNOMED, the SNOMED codes we are recommending strictly for those other fields in
HL7 that says —

DR. HUFF: For the reaction and severity —

MS. HALLEY: Exactly, exactly.

DR. HUFF: I guess one other thing is, there was other, one of the areas I
didn’t see addressed is sort of if you will the certainty of reaction and
there’s a published literature where, and I don’t know that HL7 has even dealt
with this appropriately, I know about it because we’re doing that in our own
system and have Scott Evans within our institution has done a lot of work in
this area but I mean they described basically confirm by challenge that sort of
stuff so that you, so it starts off as sort of a suspected status because
something bad happened to him and it happened of course onto a time that they
ate something or were exposed to something, but then you can challenge back or
you can do other things and confirm their reaction and I don’t know if you guys
had gotten into sort of investigating that area of —

MS. HALLEY: We do have someone on the line, Dr. Lam from the VA, who is very
knowledgeable about HL7 and I’ll certainly let him speak to this but I believe
in the transaction that to my knowledge, and I’ll let Dr. Lam respond, but that
was not one of the components within the HL7 transaction but what is a
component is who reported it, is this patient reported or provider reported and
that is one of the components.

Dr. Lam, do you know the question that Dr. Huff is asking about, I guess
it’s more the sensitivity or the susceptibility —

DR. HUFF: It’s sort of the certainty with which you know this is really,
that a substance cause this, I mean you can usually know whether they got hives
or didn’t get hives, what you don’t know is with what certainty this particular
substance actually caused that reaction and so there’s some, I guess it’s
certainty or something of association.

MS. HALLEY: Dr. Lam, are you familiar with that work? Or whether HL7
supports that?

DR. LAM: I don’t think we discussed in the CHI Workgroup and I think that
personally, we relied on the reporting system to determine that occasion, of
strength, that allergy information.

DR. HUFF: Just one other area to work on sometime.

DR. LUCCIOLI: Could I just add to that? That’s actually a very good point, I
can speak to the foods where most of our reports that come with foods are
patient derived and everyone thinks they have an allergy and studies show that
one out of five who believe they have an allergy actually do have an allergy so
it is a good point and it’s something that needs to be considered. But we did
not discuss this particular, and I don’t know how we would be able to get that
information, maybe recommend having a box that says have you been specifically
tested.

MS. ORVIS: This is Nancy Orvis at DOD, we talked about some of this issue in
the group but I think one of the things we were going to keep out of our scope
but leave to software developers to talk about, could be an augmentation, is
that issue of actually particularly as we try to stand up NHINs or regional or
interchange every hospital or health care organization will have a file of
historical allergies. And at this point in time there’s no way with much
certainty unless you recorded it on a physician’s note or something like that
that it was reported by the provider, you may or may not be able to tell with
any verification some of this issue. But you do want to transfer this
information on a patient, whether it’s provider or patient reported because
there’s no way the receiving system is going to be able to verify, they’ll just
be able to take it.

That was an interesting exchange where we talked about what to do about that
and that was one reason where in the drug area DOD advocated having a brand
name hierarchy to pick from when you were particularly trying to transfer
information that might be historical or that was patient reported where they
only know a brand name of something and they’re going to ask you to go, I got
hives, I ate this, something like this, or I took this Nyquil or some kind of
medication and can you find out if I’m allergic to it or something.

So I don’t know if that exactly addresses your answer, I think there’s more
work that can be done but I also believe that some of this is going to be very
difficult to do until the whole note with this allergy data is also in
electronic form because of that very issue of being able to say where did it
come from, did it come from a patient history or did it come from a provider
testing.

MR. REYNOLDS: Stan, are you okay with that?

DR. HUFF: Yeah, yeah.

MS. GREENBERG: I just was going to note and I saw that CDC doesn’t actually
seem to have been involved on this workgroup but I was just, in what Stan said,
there’s some parallel to that needing or wanting to know or needing to know
that level of certainty in the whole notifiable disease area where do, and
they’ve been trying to standardize that and I don’t know exactly, we were
involved at one point, I don’t know exactly what the status of this, maybe
Steve does, but about the level of certainty about you get a report, if it’s a
report, if it’s been confirmed by lab tests, if it’s, there’s a whole kind of
hierarchy of level of certainty and confirmation. And it seemed to me it was a
parallel kind of data element.

DR. STEINDEL: Marjorie, first comment with regard to CDC, CDC was aware of
this group, we chose not to participate primarily because this type of allergy
information is not really involved in any of our program areas but people at
CDC were aware of the work that was going on and we’ve never had objection to
the direction this group was going. So just because we’re not on the list of
participants that doesn’t mean we weren’t aware or weren’t —

And with regard to the second comment, there actually is an extremely formal
structure within public health for deciding, for reporting the certainty of a
reportable disease and those criteria are maintained really for each one of the
reportable conditions and are spelled out in each one of those reportable
conditions and it’s jointly decided by SCTE and the partners that are
associated with that and published on the CDC website. But I view that as a
little bit different then what Stan is bringing up because this is a very
defined criteria area that has to do with case counting and public health
information, etc., that we’ve been very precise about, whereas what Stan’s
talking about is as was mentioned an imprecise area.

MR. REYNOLDS: Judy and then I’ll close it out.

DR. STEINDEL: Harry, I have a comment, this is about the report.

MR. REYNOLDS: I want to, a couple quick things, so basically, and I’ll speak
as a layman, I’m glad everybody, this sounds good.

DR. STEINDEL: Let me go ahead —

DR. HUFF: The diversity of the group is great, the HIPAA stuff I’m going —

MR. REYNOLDS: Yes, yes, I got some process questions, I’m going there in a
minute —

DR. STEINDEL: I’m going to a process question before you go to a process
question because I think there’s one that you’re not aware of, I have a little,
I think I know where Harry’s going and I have a little bit of a problem with
the way you worded the recommendation on page 13. NCVHS in the past has
reviewed, has concurred with CHI recommendations with conditions, but you
actually say this recommendation is conditional so you’re asking us to concur
with a recommendation that really you’re saying is highly conditional, but it’s
not highly conditional, it’s only conditional with respect to a very small
sub-segment. And I would, if the group is willing to accept a recommendation
that this be changed to something like the following conditions, the following
condition needs to be met before full implementation or something like that I
think we can concur but the way it’s worded now it seems like the whole
recommendation is conditional.

MR. REYNOLDS: To show you how much we think of your group we had already
worked on a draft letter that is in the package, however, let me add, however,
that was exactly where I was going because what I think we clearly need from
your group is a recommendation that clearly specifies what we’re recommending
and what are the subsequent, I have not heard us recommend something that had
future dates necessarily that were as clearly spelled out.

So I feel a little uneasy right now so I’m pretty comfortable and I’m going
to ask everyone, I’m pretty comfortable everyone is in agreement, I am very
uncomfortable with just referencing a report that kind of leaves some things
open, so I think anything that you could do, and Steve has been kind of trying
to help us with the substance, it’s one of his areas at least for discussion,
if you could, so if you could do that so that we could clearly have what your
recommendation is, and that clearly if there’s any future stipulations does
that, are you recommending that you go forward, that we go forward, or are you
recommending that we back off? I’m not sure, in other words do we wait, I saw a
December ’08, does that say we don’t anything until December, you understand
where we’re coming from though, we need something that clearly states what
you’re really wanting us to agree to.

And I think everybody agrees to what you’re doing but I’m a little uneasy
with the way it’s stated also so that when we say yeah go, we recommend to the
Secretary yeah go, is there anything, that’s bothersome about that.

Jeff, do you have anything to add to that?

MR. BLAIR: My comments are consistent with yours and Steven, and one of the
things is in the more then eight years I’ve been on the committee I don’t
remember a time when we ever drafted a letter in advance of testimony and I
think, and I just wanted to mention something, a draft letter, and you were
good enough to share with us the document beforehand and we read it and were
very impressed, and so we wanted to make sure we didn’t hold you up so we cut a
draft and with the idea that it could be modified as questions came up when you
testified to us which is what has happened. And so I think that the little bit
of wordsmithing that Steven has suggested and Harry has suggested, if you
wouldn’t mind doing that in a manner, and by the way the phrasing that we’ve
been using in terms of the relationship between NCVHS and CHI is to be
consistent and supportive of what you’re recommending, we’ve used the word
concur, that NCVHS concurs with the CHI recommendations and I think that’s the
only reason that both Harry and Steve have wound up saying we want to make sure
that your wording for your recommendations is something where we can say we
concur with that.

MR. REYNOLDS: Rather then having to explain why a later date is good or bad,
I mean that’s where I found myself from a process standpoint, that just saying
concur, if I were somebody else, again looking at it as a layman, I wasn’t sure
what I concurred with exactly because there were dates spread out and there
were some other things. So your work was excellent and I guess I would like to
ask the committee is there any reason that anyone does not feel that moving
forward with this, through our normal process, and again don’t let draft letter
get you too excited, it’s got to go to full committee and with recent history
sometimes that’s hand to hand combat. But yours usually don’t fall into that
category and that’s a nice thing. I understand you want to have this meeting so
I guess for purposes of this session I’d just like to make sure Stan, you okay,
Jeff —

MS. ORVIS: This is Nancy Orvis, a member of the group, I wanted to get
clarity, we were trying to make a recommendation similar to what we had done in
the medication domain where there were several, there were eight or nine
subcomponents of that, that was, if you just give us the words that you want us
to revamp this, I mean within the context of the set of things that we’re
recommending for a complete set of terminologies for an allergy report domain,
there are some pieces that are conditional for implementation until the
complete set is available.

MR. REYNOLDS: I understand but I guess a couple things, on the agenda it
says preliminary recommendations so all I’m trying to do is look at the
process. It says preliminary recommendation, I don’t know if that’s one that
you want us to recommend that you just look at the words. This has multiple
pieces, just as long as it is very clearly stated what you all concur with
because one of my other questions that I have is is there anyone that you
haven’t met with that you feel could have a dissenting position on this and in
the past, you’ve got a very broad group but I’d like to see, we got eight heads
involved here, I’d love to see them shake that you feel that you’ve done the
appropriate due diligence with all the parties involved, so that’s, so
basically if you would just work with Steve, Elizabeth, just to make sure that
we have, when we see the draft letter and we’re also, we’re going to do a
couple things, we’re going to talk about another letter in a minute where we’ll
probably have an August conference call because we may want to take these two
letters to the September full committee, I just want to make sure that we have
that clearly adjudicated so that then we can do our process in August and
approve the letter, and then we can take the letter on in September so that it
officially goes to the Secretary, unless the full committee has some kind of an
issue with it it moves on so we continue our process but we do it in the
appropriate and structured manner so that we aren’t kind of doing it a little,
Steve, does that —

DR. STEINDEL: Yes.

MR. REYNOLDS: So that’s where I’d like to see it happen but you’ve done
great work and it’s exciting to hear that it could help PHR, e-prescribing has
similar kinds of issues, EHR has issues, so I think you guys are a real laid
out in the front making a big difference and we appreciate all of you taking
your time to come in and what you’ve been doing. So with that we’ll close this
particular portion of the session.

MS. HALLEY: Thank you very much.

MR. REYNOLDS: Thank you.

Agenda Item: Subcommittee Discussion

MR. REYNOLDS: All right, we had a break scheduled but I’d like to recommend
that we move on into the next section because we’ve got a couple things to
cover and the first that we were going to talk about, we were going to talk a
little bit about where we were with e-prescribing and I know that Karen has to
leave so any comments she or Denise could make on how the pilots are going plus
you all were aware there was a DEA meeting based on some of the stuff that we
were clearly involved in. So if Karen and/or Denise could give us a little
update on both of those and then we’ll continue to go to our next issues.

MS. TRUDEL: I’ll just do a few minutes discussion of the joint DEA/HHS
hearing meeting that we had several weeks ago, the purpose of it was to provide
a neutral forum in which any people who were interested in making statements
about issues related to electronic prescribing of controlled substances could
come to the table, we wanted to make sure that law enforcement perspectives
were heard as well as provider and pharmacy perspectives, we listened to
vendors and others, and the purpose was to make sure that as a result of many
discussions that we had in this venue, in the e-prescribing hearings a few
summers ago, it was very clear that —

DR. CARR: This is Justine, I’m not hearing what the speaker is saying.

MS. TRUDEL: Okay, essentially the purpose of this conference was to hear
balanced testimony from across the spectrum in terms of business requirements
and the way the e-prescribing community works today and how it could work in
the future if we were to extend e-prescribing to controlled substances.

And the discussion went in two different directions, in one sense there were
people who were advocating for a variety of technologies and it went into the
spectrum where people who were saying that a PKI solution was absolutely
necessary to meet the business processes of the DEA particularly in the area of
non-repudiation. A number of vendors and pharmacy network operators, pharmacies
themselves, were making a point that the technology that is on the ground and
running today for non-controlled substances carries with it a number of
compensating technical controls that could potentially be used to enable
e-prescribing of controlled substances without resorting to a PKI solution.

But there were other some messages that I thought were very interesting and
they included the fact that pretty much across the board there was an
acceptance of the fact that controlled substances e-prescribing had significant
requirements associated with it but that imposing additional technical
requirements on the prescriber community would slow the uptake of
e-prescribing. There was consensus that a single solution for all of
e-prescribing including controlled and non-controlled substances would
definitely encourage the adoption of e-prescribing and there was an acceptance
that e-prescribing as it is done now through the networks with physician
software, the pharmacy software, does carry with it controls, additional
controls such as audit trails that go all the way back to the prescription the
way the physician transmits it that don’t exist today in a paper network. So
there was an acceptance of the fact that there are pros and cons here and that
there’s a really significant need to start looking at these tradeoffs very
carefully.

Some interesting specifics, a number of people said that the fill status
transaction, which we discussed in this subcommittee and which was ultimately
not adopted as a foundation standard because it was not in, it didn’t have
adequate industry acceptance, and it’s being pilot tested, that the fill status
transaction provides additional safeguards because if the physician does not
send the prescription for a controlled substance, nonetheless when it’s filled
he’ll get a response back that says it was filled and dispensed, so that
provides additional information for the physician to monitor that sort of
prescribing practice.

Another point that was made was that at least 20 states have controlled
substance reporting systems and registries actually in operation today and a
number of testifiers said that having real time transaction data that could
feed into those systems would significantly increase their usability and
provide an additional audit mechanism.

Another interesting point was that the state of Ohio actually has for its
own state purposes created a set of certification criteria for pharmacy vendor
systems that relate to electronic prescribing and controlled substances so
those are some things that we’ll want to get into in a lot more detail.

Our next steps, and I would say I think the DEA and the HHS participants
were very pleased about the way the meeting ran, both sides, I think we all
learned a lot and I think there was exhibited a very definite intent to move
forward and attempt to take the next steps to see what kinds of solutions we
need to pursue. We are already pursuing setting up an additional meeting with
the DEA to debrief and talk about next steps. Clearly there’s some topics that
we want to look into in greater detail including the Ohio issue of the
certification criteria, whether any other states have similar requirements that
we could look at. And I personally came away from it with the sense that we
really were beginning to make some progress.

MR. REYNOLDS: Great, excellent report. Jeff has a question —

MR. BLAIR: Congratulations, Karen, on having this very important meeting
between the perspective of law enforcement and legal issues, with the focus
we’ve traditionally had which is on patient care, quality, patient safety, and
cost, and one of the things that I wonder if it came out in those meetings was
that since this is the first time the legal community has started to work with
us on these types of issues was there any mention or discussion in this meeting
of the implications of that because when we are starting to talk about the
Nationwide Health Information Network and we talk about the security standards
that are required for that and people wind up referring to a legal EHR, the
agreement that comes out of the discussions you’re having with the Drug
Enforcement Agency might be a new foundation, a new roadmap, a standard,
something to build on for the future in terms of what’s required for security
for a legal record. Was there any comments or discussions about that?

MS. TRUDEL: There was a fair amount of discussion about the fact that a
solution for e-prescribing and e-prescribing for controlled substances could
feed into and should be looked at in the context of a National Health
Information Network. There weren’t specific discussions about that from a legal
perspective and I would say that the legal discussion because of the people who
were present in the room was very much in terms of prosecuting diversion. So
there wasn’t the discussion in terms of liability and the legal standing of
electronic health records in general but I think it’s an interesting
convergence where we might want to get the folks who work on those issues
together with the people in the Office of the National Coordinator who are
working on the privacy and security contract with 40 plus state subcontractors.

MR. REYNOLDS: Do you see any involvement, what is the next involvement you
see from this committee on this subject?

MS. TRUDEL: I think probably timing wise since there’s a meeting in October
it might be very helpful for us to come back and report on what we have
accomplished and the discussions that we’ve had with the DEA, and to have them
come with us and co-present any proposals that we have. And I’d also like to
point out that this DEA meeting was Denise’s debut so she worked with them for
the coordination and the planning.

MR. REYNOLDS: Hallelujah, nice job. Steve.

DR. STEINDEL: Just a quick comment, Harry, on the issue that Jeff raised. I
think there’s a significant difference between what we’re talking about with
the DEA and the diversion efforts because that’s under criminal code and the
legal EHR is really handled under civil code so there’s different criteria and
barriers.

The other two things that we wanted to cover today was one, a quick
discussion on our letter, matching records, the other thing we wanted to
discuss as far as going forward is our letter that we had done which was our
draft letter on matching records to patients and what we’d like to put forward
to the subcommittee is that Judy work on, based on, we heard some testimony
yesterday through the NHIN on some of these issues and one of our agreements
was that we would wait until we heard these hearings and see how that subject
did or didn’t continue to play and/or was or wasn’t mentioned or what it did.

And so we feel that we got some further input so Judy has agreed to work on
a draft an done of the things I mentioned, an August type conference call, Judy
is going to be willing during the next week or so get a new draft out, we’re
also going to have, we’ll take, Jeff and I will take a quick look at that along
with possibly Simon and then I would like to have Jim Scanlon go ahead and take
a look at it. Then as part of our conference call we go over with the full
committee and everyone else. We know that we have a box we want to clearly stay
in and we want to clearly adjudicate appropriately, but we’ve heard what we’ve
heard and our responsibility is to discuss what we heard.

So we want to make sure that this process works accordingly so that would be
our recommendation and Judy has been gracious enough to take the first stab at
that and then we as the co-chairs along with Simon as the chair of the full
committee will at least take a look at it, and then if it looks like it’s got
the basic things in it make sure that we run by Jim at least for the discussion
to make sure that we, where we would want to in our conference call have
discussions about the distance that we do or don’t go on any of the issues.

Is that, Marjorie, are you okay with that as a process?

MS. GREENBERG: No, I certainly it came up a number of times in the two days
of hearings and I think it would be very appropriate to pull in the information
that you got, I said it did come up a number of times, the topic, it was one of
the highest priority topics it seems. So you’re talking about a separate
conference call, or one of the NHIN conference calls?

MR. REYNOLDS: No, no, we’re talking about a this committee conference call
on our letter on CHI and on this letter.

MS. GREENBERG: I just think it’s, one of the problems or one of the issues
that I think occurred at the June meeting was that clearly this topic of
matching patients with their records is replete with privacy confidentiality
issues and the committee was putting forward a major letter on those issues and
the NHIN and so there was some, a certain amount of confusion or at least
overlap or concern about one of them, which one were we talking about. And of
course the same thing could happen again with the NHIN, so obviously it’s the
same people, you’re all on both committees —

MR. REYNOLDS: I was just going to say, I think it’s hard to differentiate
which is which.

MS. GREENBERG: It was putting different hats on but I do think it’s very
important to make sure that the two letters are very coordinated and as I said
it’s the same people but I mean even in the language.

MR. REYNOLDS: No, I think that’s a great idea. Why don’t we look at, and I
just saw an email this morning about all the calls that have been set up on
that for August and early September, which is I think five, four or five, so
what I’d like to do is as Judy gets this draft out then work with Simon to
possibly just go ahead and make this letter at least discussed during one of
those discussions, the CHI letter shouldn’t take us real long in that so try to
put these two letters in that so that we’re not adding another set of calls,
because the CHI shouldn’t take long and this relates to both committees
clearly.

MS. GREENBERG: And given the importance of this issue I’m wondering if in
fact the open web based call or whatever that you’re planning at the end of
August might not, this might not be a component of that. I’m just suggesting
that as a possibility —

MR. REYNOLDS: And I’m agreeing with you, I’ll work with Simon to make sure,
Jeff and I ought to make sure we’re each comfortable. But I just wanted to make
sure everybody understood how we’re trying to move it forward, how we’re trying
to move it forward.

So the only other thing that I wanted to make sure we covered as Jeff and I
talked about it is so we have an October hearing scheduled and so far I know
that we have the CHI coming back to discuss with us, NPI obviously is a subject
that we can’t wait much past October to have a much more robust discussion, I
think WEDI represented a significant portion of the industry but we do need to
hear from individual voices on that subject because I think some kind of a
letter will probably be necessary because you got the industry writing to the
Secretary, you obviously have CMS doing some things and obviously we are kind
of supposed to be the glue that pulls a lot of this together at times and so I
think it is very appropriate for us to adjudicate this once more and put
forward some kind of recommendation on it. And then obviously the
e-prescribing, the DEA/CMS, it might not be bad to have an update from the
e-prescribing pilots, that would be a good time to probably have that.

So I think that itself could probably end up being the day and a half that
we would want to get together but I’m open, I’ve kind of gone through our chart
which we’ve been kind of torn asunder a number of times as to what the heck
we’re doing but we covered this in the Executive Committee and as I looked
through it earlier a couple of exciting things actually is most of our subjects
are getting dealt with, and secondly a lot of what was on here as
considerations are actually now happening, so that’s kind of fun. But at the
October meeting I’d like to set aside some time, Denise, also to make sure that
we get ourselves a good roadmap based on what we’re hearing with NHIN or
anything else for Standards and Security to keep moving, so that this doesn’t
just become kind of a stale document and then all of a sudden everything kind
of slows down on some of the other and we’re sitting here with no good plan.

Does that sound reasonable to everyone as what we would do in October? Judy?

DR. WARREN: You’re talking about the October meeting, what are the dates for
that?

MR. REYNOLDS: October 11th and 12th, yes, it’s been on
the calendar —

Justine, did you have anything to add? I’m sure you might be waving your
arms right now but I can’t see it.

DR. CARR: No, Harry, I’m learning, I don’t have anything to add, I’ve been
following the discussion though.

MR. REYNOLDS: Does anybody have anything to add other then that and if not I
will adjourn us. Denise, we are very happy to have you with us, we are very
excited about that, thanks to all the staff and thanks to everyone, Justine,
thanks for joining us and we’ll consider the meeting adjourned. Thank you very
much.